Kornimate/medical-research-clean huggingface dataset:
surgical ablation of af efficacy trial

Conditions: Atrial Fibrillation; Heart Failure

Summary: safe is an international multicentre rct of concomitant surgical atrial fibrillation (af) ablation in patients with paroxysmal or persistent af undergoing cardiac surgery.

atrial fibrillation (af) affects more than 1% of the general population and is an important risk factor for stroke. af prevalence increases with age, occurring in 10 to 15% of patients older than 80 years of age, which is important with the aging population. of patients undergoing cardiac surgery, 10.8% have a history of af. af is believed to cause the left atrium to dilate and lose its transport function. af significantly increases the risk of ischemic stroke of cardioembolic origin, but is also associated with heart failure and impairs quality of life. although the causal relationship between the 2 clinical entities has not been fully elucidated, af is believed to cause heart failure via several mechanisms. ablation of af is the application of scars to the atrial tissue to disrupt faulty electrical signals that cause the arrhythmia. if surgical ablation of af yields a benefit similar to catheter-based af ablation, thousands of people undergoing cardiac surgery could benefit from this procedure each year. safe will be a landmark trial in cardiac surgery, definitely establishing surgical af ablation's impact on cardiovascular outcomes. cardiac surgery is the optimal setting to establish whether maintenance of sinus rhythm through af ablation yields clinical benefit, and is a setting where sham-control is possible. this will not only provide evidence for the cardiac surgical patients but will bolster the evidence for ablation (catheter or stand-alone surgical) in other af patients. the intervention under investigation is concomitant surgical af ablation which is compared to no surgical af ablation. the primary outcome is hospital readmissions with heart failure during 4 years of follow-up. this study will enroll 2000 patients from 50 centres, globally. patients will be followed at hospital discharge, 4 to 6 weeks after surgery, 6 months after surgery, and then at 6-month intervals until the final follow-up visit, for a median follow-up for 4 years.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years; * undergoing a clinically indicated cardiac surgical procedure: cabg, avr, ascending aorta replacement, or combinations thereof; * documented history of paroxysmal or persistent af * provide informed consent exclusion criteria: * dominant atrial arrhythmia is atrial flutter; * documented left atrial diameter ≥ 6 cm; * previous cardiac surgery requiring opening of the pericardium; * patients undergoing any of the following procedures: 1. heart transplant 2. complex congenital heart surgery 3. sole indication for surgery is ventricular assist device insertion 4. mitral valve repair or replacement 5. tricuspid valve repair or replacement * patient resides in a long-term care facility

Keywords: surgical ablation cardiac surgery
progressing taar-1, dopamine, and norepinephrine in depression using solriamfetol

Conditions: Major Depressive Disorder

Summary: paradigm (progressing taar-1, dopamine, and norepinephrine in depression using solriamfetol) is a phase 3, randomized, double-blind, placebo-controlled, multicenter trial to assess the safety and efficacy of solriamfetol for the treatment of major depressive disorder (mdd) in adults.

eligible subjects must have a primary diagnosis of mdd without psychotic features based on the diagnostic and statistical manual of mental disorders fifth edition (dsm-5) criteria. subjects will be randomized in a 1:1 ratio to receive either solriamfetol (300 mg) or placebo for 6 weeks.

Eligibility criteria:
inclusion criteria: * currently meets the dsm-5 criteria for mdd without psychotic features, based on the scid-5-ct * current major depressive episode * male or female, aged 18 to 65 inclusive exclusion criteria: * prior exposure to solriamfetol/sunosi, through either a clinical study or prescription * unable to comply with study procedures * medically inappropriate for study participation in the opinion of the investigator

Keywords: solriamfetol sunosi mdd major depressive disorder axsome non-stimulant therapy dopamine norepinephrine reuptake inhibitor trace amine-associated receptor 1 (taar1) agonist
comparison between lactulose and lactulose-paraffin in cirrhotic patients

Conditions: Cirrhosis; Hepatic Encephalopathy

Summary: hepatic encephalopathy (he) is an important complication of liver cirrhosis. lactulose is a first line treatment for he, but the adherence to this treatment is relatively low, due to side effects such as diarrhea, distention, etc.

lactulose is a first line treatment for he, but the adherence to this treatment is relatively low due to side effects. lactulose-paraffin recently available in the market can be used for the treatment of he, and possibly have fewer side effects. the aim of this study was to compare the adherence of the treatment of lactulose and lactulose-paraffin.

Eligibility criteria:
inclusion criteria: * liver cirrhosis * history of an event of hepatic encephalopathy. * ambulatory patients exclusion criteria: * alcoholism with active ingest of alcohol in the last 6 months * labour turn-overs * pregnancy * personal history of surgery in the last 4 weeks * spontaneous bacterial peritonitis * use of neuropsychiatric drugs * neuropsychiatric disorders (schizophrenia, bipolar disorder, major depression, dementia and attention-deficit hyperactivity disorder) * thyroid disorders without replacement therapy * renal failure * hepatic or renal transplant * personal history of hepatocellular carcinoma * placement of transjugular intrahepatic portosystemic shunt * use of a probiotic in the last 6 month
evaluation of carbothera in the treatment of foot ulcers

Conditions: Critical Lower Limb Ischemia; Critical Limb Ischemia; Foot Ulcer; Skin Ulceration

Summary: foot ulceration usually precedes more serious foot complications such as infection, gangrene or amputation. the risk of developing foot ulcers has been estimated to be higher in individuals with kidney disease. patients with kidney disease receiving dialysis have an increased prevalence of critical limb ischemia. carbon dioxide (co2) foot bathing has been reported to improve subcutaneous microcirculation. the proposed clinical study will evaluate the therapeutic potential of co2 enriched water (produced by the carbothera device) on treating foot ulcers in patients with critical limb ischemia and undergoing hemodialysis. forty individuals how have a distal extremity ulcer who are currently undergoing hemodialysis will participate in this study.

this is a multi-centered, placebo controlled and randomized clinical study designed to evaluate the therapeutic potential of co2 enriched water on the treatment of distal extremity (foot) ulcers in patients with critical limb ischemia undergoing hemodialysis. study participants will be patients receiving dialysis at two local hospitals in winnipeg and will have been diagnosed with cli and foot ulceration. patients will be randomized to receive either treatment with co2-enriched tap water, 1,000-1200 ppm co2 (treatment group), or non-enriched tap water (control group), bath therapy at 37ºc on the same day as dialysis (typically 3 times/wk), for 15 min for 4 months,. blood (approximately 20 ml) will also be collected at baseline and at the end of every month of the treatment period (for a total of 5 collections) for the measurement of the different biomarkers.

Eligibility criteria:
inclusion criteria: 1. male and female participants ≥ 18 years of age with at least one distal extremity ulcer (arterial ischemic ulcer). 2. no acute medical illness and on conventional medical management prior to carbothera. 3. willingness and ability to provide written informed consent exclusion criteria: 1. dvt or pe within 12 months. 2. subjects with known active cancer, hiv, hepatitis b virus, hepatitis c virus, human transmissible spongiform encephalopathy, treponema pallidum. 3. subjects who are deemed to have an infection of the distal extremity ulcer. 4. women who are pregnant 5. unstable angina. 6. acute mi within 1 month. 7. stroke within 1 month. 8. patient scheduled for revascularization during the 4-month intervention period.

Keywords: critical limb ischemia limb ischemia wound care hemodialysis dialysis skin ulceration
effects of cp-690,550 (tasocitinib) on cholesterol metabolism in patients with active rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the purpose of study is to explore the effect of cp-690,550 (tasocitinib) on cholesterol metabolism in patients with active rheumatoid arthritis (ra).


Eligibility criteria:
inclusion criteria: * males or females, 18 years of age or older with active rheumatoid arthritis; or male and female healthy volunteers 18 years of age and older exclusion criteria: * pregnant or lactating women * clinically significant systemic disease (other than ra for ra arm) * use of lipid-regulating agents

Keywords: cholesterol metabolism cholesterol flux rheumatoid arthritis tasocitinib cp-690 550
effect of supplementation of bioactive compounds on the energy metabolism of people living with hiv / aids

Conditions: HIV Infections

Summary: among the many changes associated with the impact of hiv and the long-term use of antiretroviral therapy, metabolics are important because they are important risk factors for the development of cardiovascular diseases. the objective of the present study is to evaluate the effect of the supplementation of curcumin, on the oxidation of resting energetic substrates in hiv / aids patients. the sample will be composed of adults living with hiv / aids on antiretroviral therapy for at least 6 months. supplements will be made separately for 30 days and will be evaluated before and after the intervention the following parameters: body composition, energy metabolism, biochemical parameters and a structured anamnesis. food consumption and the level of physical activity of the volunteers will be controlled.

the study is characterized as a double-blind randomized clinical trial. participants in the study will be adults living with hiv / aids who undergo regular clinical follow-up at some specialized hiv / aids care service. the sample will consist of 20 volunteers, 10 in the experimental group (ge) and 10 in the control group (cg). participants will be randomly assigned to one of the groups by lottery by a researcher not participating in the study. the researcher responsible, as well as the volunteers, will not be aware of which participants are in the ge or the gc. the study will be carried out in the movement laboratory of the physical education department of the federal university of rio grande do norte.

Eligibility criteria:
inclusion criteria: * antiretroviral therapy has been available for at least 6 months, aged 18 years or over. exclusion criteria: * individuals with endocrine and pregnant disorders will be excluded.
wheezometer™ exploratory (wm) field study

Conditions: Respiratory Sounds; Wheezing

Summary: karmel sonix ltd has developed the personal wheezometer a hand-held pulmonary sounds analyzer that utilizes contact sensors to acquire, amplify, filter, record and quantify the presence of wheezing. when used to monitor conditions such as asthma, this device should be used under the direction of a physician or licensed healthcare professional. the device is intended for use with pediatric and adult patients in both home and clinical settings. the purpose of the study is to determine whether wz% and change in wz% correlate with symptoms and change in symptoms at least as well as fev1 and change in fev1.0. additional information to be obtained from the study will be to determine whether there is a symptom threshold at which a patient seeks rescue medications and if so, to determine the value of wz% and fev1.0 at this point (wz%, fev1.0 thresholds). the study will also provide information on the within patient and whole group correlations between wz% and fev.


Eligibility criteria:
inclusion criteria: * physician diagnosed asthma. * poorly controlled asthma as per gina guidelines with frequent (i.e. \>5/week) use of reliever medications. * adequate comprehension level and demonstrated ability to perform unsupervised spirometry, wheezometry and use the symptom diary. * age range 8-80. patients over 40 will only be included if they are lifetime non-smokers, who have demonstrated reversibility of airway obstruction (at least 12% improvement in fev1.0 after bronchodilator). * all patients included in the study will be routinely receiving either a short acting bronchodilator or a long acting bronchodilator twice daily as part of their regular medication. additional doses of bronchodilator will be taken on an as needed basis. no change in regular medication will be made for the purposes of the study. * subject or subject's parents/guardians is/are able to comprehend and give informed consent for participation in the study. consent of treating physician. exclusion criteria: * inability to perform spirometry and/or wheezometry. skin disorder (burn, infection, or allergy) over upper chest (child) or neck (adult). * patients with other diseases, which in the opinion of the treating physician would interfere with the management of asthma and performance of the study according to the protocol. * hospitalization at recruitment, \[patients who get admitted while participating will continue to participate\]. p- hysician objection.

Keywords: wheeze measurements
the relationship between fasting time and delirium

Conditions: Delirium; Sedation Complication; Magnetic Resonance Imaging; Fasting

Summary: we investigated the relationship between fasting times and delirium in children undergoing mri under anesthesia. paediatric anaesthesia emergence delirium (paed) scale, last oral intake time and type of food (solid-liquid) and fasting time, laryngospasm, desaturation (spo2 \<95%), bradycardia, allergy, nausea and vomiting were recorded.


Eligibility criteria:
inclusion criteria: * children between the age group 2-6 years of american society of anesthesiologists (asa) physical status i or ii * patients undergoing mri under sedation exclusion criteria: * asa 3-4-5 * under 2 years old, over 6 years old * cognitive or psychological disorder * serious central nervous system diseases, including a brain tumor or uncontrolled seizures * type 1 diabetes * detection of ≤ 50 mg/dl in fasting blood glucose measurement * whose parents did not want to participate in the study

Keywords: emergence delirium pediatric preoperative fasting magnetic resonance imaging
an observational study of local relapse after high grade osteosarcoma

Conditions: Osteosarcoma

Summary: multicenter retrospective and prospective study in patients with high-grade osteosarcoma

this is a multicenter retrospective and prospective study that will analyze all cases with of diagnosis of local relapse in high-grade osteosarcoma from 01 january 1980 and all new cases referring to each participant site.

Eligibility criteria:
inclusion criteria: * patients who experienced lr as first event of recurrence after treatment for localized high-grade osteosarcoma of bone, including cases with synchronous lung metastases * adequate patient compliance to follow-up visits * written informed consent prior to any study-specific analysis and/or data collection * no age limits exclusion criteria: * cases of lr demonstrated after \> 3 months after metastatic disease * impossibility to ensure adequate compliance
keepap device for treatment of obstructive sleep apnea

Conditions: Obstructive Sleep Apnea

Summary: the aim of the study is to test the hypothesis that a new device would produce a significant decrease in obstructive breathing events during sleep as indexed by the apnea hyperpnoea index (ahi) or respiratory disturbance index (rdi) and measures of oxygen saturation during sleep.

obstructive sleep apnea (osa) syndrome is a disorder characterized by repetitive episodes of upper airway obstruction that occur during sleep. associated features include loud snoring and fragmented non-refreshing sleep and have profound impact on quality of life, on safety on the roads and at work, and on the cardiovascular and metabolic systems. the aim of the study is to test the hypothesis that a new device would produce a significant decrease in obstructive breathing events during sleep as indexed by the ahi/rdi and measures of oxygen saturation during sleep.

Eligibility criteria:
inclusion criteria: * age over between 18 and 80 years old; * ahi/rdi \> 5 exclusion criteria: * uncontrolled or serious illness (angina/myocardial infarction, cancer, stroke, dementia, congestive heart failure), * exhibiting any flu-like or upper respiratory illness symptoms at time of assessment; * history of severe nasal allergies or sinusitis or difficulty breathing through the nose; * persistent blockage of one or both nostrils; * any previous operation or trauma to the nose; * any nasal, facial or head abnormalities that would not allow adequate placement of the device. * previous diagnosis of insomnia, narcolepsy, periodic limb movement disorder, respiratory failure. * female subjects of childbearing age were excluded if they were pregnant or intending to become pregnant.
turmeric for patients with basal joint arthritis

Conditions: Thumb Osteoarthritis

Summary: the aim of this study is to assess whether the use of a commercially available nutraceutical, turmeric, is an effective option to manage pain and stiffness in patients with basal joint arthritis. to conduct a pilot randomized controlled trial evaluating the impact of turmeric on basal joint arthritis.


Eligibility criteria:
inclusion criteria: * 40 years of age or older * english fluency and literacy * seeking care for basal joint pain * tender over basal joint * positive distraction rotation test (rotation of the thumb metacarpal base while applying axial traction) * radiographic evidence of eaton stage 1 and 2 only exclusion criteria: * secondary gains (litigations or worker compensation) procedures that may interfere with patients' motivation for treatment * inability or unwillingness to participate in a trial study * rheumatoid arthritis or other inflammatory disorder diagnoses * post-traumatic osteoarthritis * patients on coumadin/steroids/nsaids/tylenol * diabetes mellitus * pregnant or lactating women * basal joint arthritis of eaton stage 3 * patients seeking other treatment for their basal joint arthritis (splint, corticosteroid injection, surgery)
acupoint application in patients with stable angina pectoris (aasap)

Conditions: Stable Angina Pectoris

Summary: hypothesis: acupoint application is effective for managing chronic stable angina pectoris. aim: to evaluate the efficacy and safety of acupoint application on the specific acupoints for chronic stable angina pectoris. design: a randomized, controlled,double blind trial. 200 participants will be included. four arms: herbal medicine application on acupoint group , placebo application on acupoint group , herbal medicine application on non-acupoint group and placebo application on non-acupoint group.

acupoint application with herbal medicine is a kind of external treatment of traditional chinese medicine and has a long history in china, which is use herbal medicine made of plaster and stick to specific acupoints, using the double effects of acupoints and herb to treat disease. in china, acupoint application with herbal medicine has been used in clinical treatment of angina pectoris, but there is no convincing evidence for the efficacy of acupoint application for angina pectoris, due to low methodologic quality and small sample size. the investigators designed the randomized, controlled, double blind clinical trial to investigates the efficacy of acupoint application in treating angina pectoris, the purpose of this study is to provide the convincing evidence for acupoint application treatment of angina pectoris.

Eligibility criteria:
inclusion criteria: 1.meet the diagnostic criteria of american college of cardiology(acc)/american heart association (aha) angina pectoris of coronary heart disease. 2.35 ≤ age ≤ 85 years, both male and female. 3.the onset of angina pectoris≥3 months, and the frequency of angina attack≥2 a week. 4.patients signed the informed consent exclusion criteria: 1. age≤35 or age≥85. 2. pregnant women or women in lactation or women of child bearing potential plan to conceive in the recent six months. 3. history of diabetes. 4. co-infection or bleeding, allergic. 5. currently participating in other clinical trials

Keywords: acupoint application,stable angina pectoris,herbal medicine
neoadjuvant study of pyrotinib and trastuzumab plus chemotherapy in patients with her2 positive breast cancer

Conditions: HER2-positive Breast Cancer

Summary: this is a prospective, open-label,multicenter phase ii study for evaluating the efficacy and safety of neoadjuvant pyrotinib and trastuzumab plus chemotherapy as neoadjuvant treatment in her2 positive early stage or locally advanced breast cancer.

the investigators hypothesized that the experimental group (pyrotinib+trastuzumab+docetaxel+ carboplatin) could have a higher pathological complete response (pcr) rate than the control group (trastuzumab+docetaxel+ carboplatin) in neoadjuvant chemotherapy. it is proposed that 268 participants will be enrolled in this study. the target population is women with early breast cancer (stage of t2-3n0-3m0) who are eligible for primary systemic therapy. the primary objective of the trial is to determine the pcr rate. the secondary objective of the trial is to determine the event-free survival(efs), disease-free survival (dfs), distance disease-free survival (ddfs), objective response rate (orr) rate.

Eligibility criteria:
inclusion criteria: 1. female patients, 18 years ≤ age ≤75 years； 2. performance status- eastern cooperative oncology group (ecog) 0-1; 3. histologically confirmed invasive breast cancer（early stage or locally advanced） 4. her2 positive (her2+++ by ihc or fish+) 5. known hormone receptor status. 6. cardiovascular: baseline left ventricular ejection fraction (lvef)≥55% measured by echo 7. signed informed consent form (icf) exclusion criteria: 1. metastatic disease (stage iv) or inflammatory breast cancer. 2. previous or current history of malignant neoplasms, except for curatively treated: basal and squamous cell carcinoma of the skin, carcinoma in situ of the cervix. 3. clinically relevant cardiovascular disease: known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110); 4. unable or unwilling to swallow tablets.